Manufacturing Systems Lead
MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.
Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.
Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.
Purpose of Job
As the Manufacturing System Lead, you will be responsible for developing, monitoring and improving systems that drive excellent performance across a balanced scorecard of safety, quality, service, cost, improvement and people within the MeiraGTx Manufacturing organisation.
- Responsible for systems improvement within manufacturing (safety, quality, flow, cost, people, improvement, strategy)
- Responsible for performance monitoring, trending and improvement for safety and GMP compliance activities within Manufacturing
- Conduct audits within the manufacturing group, ensuring compliance is maintained at all times.
- Maintain and improve a robust and compliant training system for Manufacturing
- Support, coach and influence Manufacturing Team Leaders and their teams to improve quality and safety performance
- Project management and delivery of improvements to the manufacturing process, procedures, and ways of working
- Lead internal investigations into manufacturing deviations and safety incidents
- Lead external inspection planning and readiness for Manufacturing and front manufacturing GMP aspects during audits and inspections
Key Performance Indicators
- Safety performance of Manufacturing including compliance
- Quality performance of Manufacturing including compliance
- Preparedness and performance in internal audits and external inspections
- All Manufacturing team members driving continuous improvement
- Development and training of team and self
Key Job Competencies
- Problem Solving – Identifies and resolves problems in a timely manner; able to gather and analyze information; develops alternative solutions; works well in group problem solving situations
- Systems thinking – understands interrelationships between activities and systems and optimises ways of working to deliver the best overall results
- Influencer – understands how to influence people with diverse backgrounds at different levels of the organisation to adopt better approaches consistently
- Change management – capable of planning and executing change in a way that people understand and adopt into their daily work
- Data driven – highly proficient in acquiring, manipulating and analysing data to support performance improvement
- Leadership – exhibits confidence in self and others
- Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence;
- Planning/Organizing – prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives
- Professionalism – approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
- Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
- Innovation – meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
- Oral Communication – speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
- Written Communication – writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
- University degree or HNC/HND in Science or Engineering
- Experience in pharmaceutical product manufacture
- Strong background in manufacturing operations and quality systems
- Ability to work collaboratively with colleagues and peers from a range of functions and backgrounds in a results-driven, team-oriented environment
Good understanding of GMP